The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Dx Swivelock Sl With Forket Eyelet 3.5 X 8.5mm, Arthrex Dx Swivelock Suture Anchor, 3.5 X 13.5mm.
Device ID | K150648 |
510k Number | K150648 |
Device Name: | Arthrex DX SwiveLock SL With Forket Eyelet 3.5 X 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 X 13.5mm |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | ARTHREX, INC. 1370 CREEKSIDE BOULEVARD Naples, FL 34108 -1945 |
Contact | Laura Medlin |
Correspondent | Laura Medlin ARTHREX, INC. 1370 CREEKSIDE BOULEVARD Naples, FL 34108 -1945 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-03-12 |
Decision Date | 2015-08-20 |
Summary: | summary |